Challenges in assessing change in autistic adults: scale limitations and discrepancies in reporting in clinical trials.

Autism Spectrum Disorder (ASD) is a developmental disorder marked by deficits in social communication and social interaction, together with restricted and/or repetitive patterns of behaviours, activities or interests. As more adults are being diagnosed with ASD, and more diagnosed children are aging into adulthood, the need for effective treatments and support services for autistic adults is quickly growing. As such, clinical research targeting autistic adults has emerged in recent years. Currently, caregiver ratings are commonly used as outcome measures in child treatment studies, but these scales present challenges when utilised to assess the autistic adult population. In this commentary, we seek to unveil the difficulties and obstacles in assessing change in clinical treatment trials for autistic adults. Specifically, this article uses case examples to explore the limitations of rating scales. Steps for improving the accuracy of ratings, and for developing novel self-rating scales for autistic adults are discussed. It is hoped that in exploring these difficulties in more depth, clinical research with adult ASD populations will continue to improve and that reliable, valid and sensitive outcome measures will be developed to ensure the highest quality treatments emerge.

Randomized crossover feasibility trial of helminthic Trichuris suis ova versus placebo for repetitive behaviors in adult autism spectrum disorder.

Objectives: Inflammatory mechanisms are implicated in the aetiology of autism spectrum disorder (ASD), and use of the immunomodulator Trichuris suis Ova (TSO) is a novel treatment approach. This pilot study determined the effect sizes for TSO versus placebo on repetitive behaviours, irritability and global functioning in adults with ASD.Methods: A 28-week double-blind, randomised two-period crossover study of TSO versus placebo in ten ASD adults, aged 17-35, was completed, with a 4-week washout between each 12-week period at Montefiore Medical Center, Albert Einstein College of Medicine. Subjects with ASD, history of seasonal, medication or food allergies, Y-BOCS ≥6 and IQ ≥70 received 2,500 TSO ova or matching placebo every 2 weeks of each 12-week period.Results: Large effect sizes for improvement in repetitive behaviours (d = 1.0), restricted interests (d = 0.82), rigidity (d = 0.79) and irritability (d = 0.78) were observed after 12 weeks of treatment. No changes were observed in the social-communication domain. Differences between treatment groups did not reach statistical significance. TSO had only minimal, non-serious side effects.Conclusions: This proof-of-concept study demonstrates the feasibility of TSO for the treatment of ASD, including a favourable safety profile, and moderate to large effect sizes for reducing repetitive behaviours and irritability.Clinicaltrials.gov: NCT01040221.

Why Is It Easier to Get Mad Than It Is to Feel Sad? Pilot Study of Regulation-Focused Psychotherapy for Children.

OBJECTIVE:: This article reports results of a pilot study of three participants receiving regulation-focused psychotherapy for children (RFP-C), a manualized, short-term, psychodynamic treatment for children with oppositional defiant disorder and other externalizing problems. RFP-C targets implicit emotion regulation while using an intensive, psychodynamic, play therapy approach to decrease the child's need for disruptive behaviors. METHODS:: Three children with oppositional defiant disorder participated in a trial of RFP-C. Externalizing symptoms were assessed with the Oppositional Defiant Disorder Rating Scale, and emotion regulation was assessed with the Emotion Regulation Checklist. RESULTS:: All three children improved in accordance with expectations. Participants exhibited clinically significant and reliable change, as assessed by the primary symptom measure, and demonstrated improved capacity for emotional regulation. CONCLUSIONS:: Results suggest that RFP-C has the potential to produce significant improvements in emotion regulation capacity and in symptoms of oppositional defiant disorder. This pilot study provides initial support for RFP-C as an efficacious and cost-effective intervention, with high treatment compliance rates, and lays the groundwork for a randomized controlled trial of the intervention.